Cardiovascular Disease RiskRATENCT06113484
Impact of a Mediterranean Diet on Cardiovascular Disease Risk Factors
A study testing DIET + EXERCISE and WITHOUT DIET + EXERCISE in people with Cardiovascular Disease Risk, run by Universidade Católica Portuguesa at 1 site in Portugal.
Trial summary
This approved and funded research project is part of a larger project titled "Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR): personalized exercise protocol in the rehabilitation after acute myocardial infarction or at risk of cardiovascular disease and knee osteoarthritis, a multicenter… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Disease Risk
- What is being tested?
- DIET + EXERCISE and WITHOUT DIET + EXERCISE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jun 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 50 years
- Individuals meeting the criteria for high cardiovascular disease risk in the SCORE2 or SCORE2 O.P algorithm
- Autonomy in activities of daily living
- Provide informed and clarified consent
Who cannot join
- Occurrence of Acute Myocardial Infarction (AMI)
- To receive nutritional counseling from a registered dietitian
- To follow a vegetarian or strict vegetarian dietary pattern
- To take nutritional supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Mediterranean Diet (gReenheArTediEt - RATE) on Cardiovascular Disease Risk Factors: a Randomized Clinical Trial.
This approved and funded research project is part of a larger project titled "Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR): personalized exercise protocol in the rehabilitation after acute myocardial infarction or at risk of cardiovascular disease and knee osteoarthritis, a multicenter clinical intervention study".
The main objective of this work is to quantify the effect of a nutritional and physical activity intervention in improving important risk factors for cardiovascular disease, such as body weight, body composition, and waist circumference.
Read the detailed description
Cardiovascular diseases are the leading cause of death worldwide and one of the main contributors to diminished quality of life. It is estimated that in the year 2019, approximately 17.9 million individuals died due to this non-communicable disease, accounting for 32% of all global deaths. It is considered that CVDs result from the interaction between genetic predisposition (non-modifiable risk factors) and environmental influences (modifiable risk factors). Environmental factors prevail over others and often lead to negative outcomes through the adoption of poor lifestyles, such as imbalanced nutrition, physical inactivity, smoking, and alcohol habits. These are considered risk factors with direct effects on the pathogenesis of CVDs, and indirectly contribute to increasing the risk for predisposition to chronic diseases such as hypertension, dyslipidemia, overweight, obesity, and diabetes mellitus.
Currently, scientific literature has demonstrated the importance of diet in preventing CVDs and how it can minimize their risk factors. The Dietary Approaches to Stop Hypertension, Mediterranean dietary pattern, vegetarian diet, EAT-Lancet diet, and other dietary strategies have been published in various scientific journals.
Parallel to health, another topic that has gained prominence in the scientific community is environmental degradation derived from current food production. With the projected population growth until 2050, reaching 10 billion, the effects of food production on greenhouse gas emissions, nitrogen and phosphorus pollution, biodiversity loss, and water and land use are predicted to reach such high values that they will lead to the destabilization of the Earth system.
Considering that diet holds both environmental value and promotes cardiovascular health, this study aims to explore more sustainable and health-promoting dietary adaptations. This intervention will be based on principles of the Mediterranean diet, integrating higher consumption of plant sources compared to other mentioned patterns, and also leveraging the benefits of chronobiology, which are important for weight and adiposity control.
RECRUITMENT PLAN Participants will be recruited from the Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR) project, carried out under the Algarve Biomedical Center - Research Institute. After the participants are integrated into the A3-COR project, those who meet the requirement of never having suffered from AMI but have high cardiovascular disease risk criteria according to the SCORE2 or SCORE2 O.P. algorithm will be contacted by phone. At this point, the objective of the nutritional intervention and the necessary conditions for participation will be explained (assessment of the remaining inclusion and exclusion criteria). After verifying these criteria, they will be invited to voluntarily participate in the present study. Those who accept to join the study will be contacted again to schedule the initial evaluation, and must sign the informed consent form prior to that.
PARTICIPANTS ALLOCATION Participants of the A3-COR control group who agree to participate in the present study (RATE) undergo an initial evaluation, forming the group (NO DIET + NO EXERCISE). These participants were randomly selected using new computer-generated numbers until a sample of 30-35 participants was reached from the total of 74 participants in this group. Participants from the Exercise Group of the A3-COR project who express interest in participating in the RATE project undergo randomization by numbers into one of two groups: the (EXERCISE + NO DIET n=30-35) group, which continues the exercise sessions as planned in the A3-COR project, and the (EXERCISE + DIET n=30-35) group, which, in addition to the exercise sessions, also receives nutritional guidance. This randomization is conducted among the 74 participants in the Exercise Group of the A3-COR project.
STATISTICS The statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 27.0. All normally distributed numerical variables will be presented in the format of mean ± standard deviation. The normality of the variables will be tested using the Kolmogorov-Smirnov test. Differences between groups will be determined using paired t-tests. Repeated measures ANOVA will be used to detect changes between and within groups. Results will be considered statistically significant for p<0.05.
- Conditions
- Cardiovascular Disease Risk
- Being tested
- DIET + EXERCISE, WITHOUT DIET + EXERCISE
- Keywords
- Cardiovascular disease, Risk factors, Mediterranean Diet, Plant-based Diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIET + EXERCISEOther
At first, a two-hour group session titled 'Discovering New Flavors' is conducted. This session aims to promote the consumption of healthy foods that should be included in the participants' daily diet. In order to create a different dynamic and enhance interaction, some recipe suggestions are prepared in a group setting. The intervention group is advised to have three (breakfast, lunch, and dinner) to four (breakfast, lunch, afternoon snack, and dinner) daily meals. Participants are encouraged not to count calories, thus emphasizing the importance of moderation. Regarding the main meals, legumes are recommended as a protein source for dinner. On the other hand, for lunch, the protein component can include white meats, fish, or eggs. Red and/or processed meats are excluded in this intervention. Moreover, all participants in this group are encouraged to practice a nightly fasting period of at least 12 hours.
WITHOUT DIET + EXERCISEOther
An educational session titled "Healthy Eating: Nutritional Recommendations for Individuals at Risk of Cardiovascular Disease" will be conducted in a group setting.
The objective of this session is to raise awareness among participants about the importance of a healthy diet and lifestyle in the prevention of cardiovascular diseases.
| Study group | Role | What they receive |
|---|---|---|
| DIET + EXERCISE | Experimental | This group engages in physical exercise plus a nutritional intervention. Monthly individual nutrition consultations are conducted. Additionally, this group also benefits from a group culinary workshop. Receives: Other: DIET + EXERCISE |
| WITHOUT DIET + EXERCISE | Other | This group engages in physical exercise; however, it is not the target of the nutritional intervention. Only a group educational session is conducted. Receives: Other: WITHOUT DIET + EXERCISE |
| WITHOUT DIET + WHITOUT EXERCISE (CONTROL) | No intervention | This group does not engage in physical exercise, nor is it the target of the nutritional intervention. Only a group educational session is conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions
Measured: Day 1
Body weight (kg)
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions
Measured: Day 90
Body fat (%)
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Measured: Day 1
Body fat (%)
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Measured: Day 90
Waist circumference (cm)
The abdominal circumference is assessed using a measuring tape at the midpoint between the upper edge of the iliac crest and the last palpable rib, following the methodology established by ISAK (International Society for the Advancement of Kinanthropometry)
Measured: Day 1
Waist circumference (cm)
The abdominal circumference is assessed using a measuring tape at the midpoint between the upper edge of the iliac crest and the last palpable rib, following the methodology established by ISAK (International Society for the Advancement of Kinanthropometry)
Measured: Day 90
Secondary outcomes (28)
Lipid profile
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample. The values presented refer to total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.
Measured: Day 1
Lipid profile
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample. The values presented refer to total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.
Measured: Day 90
Hemoglobin A1c
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample.
Measured: Day 1
Hemoglobin A1c
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample.
Measured: Day 90
C-reactive protein
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample.
Measured: Day 1
C-reactive protein
Collection of a capillary blood sample by pricking the finger using a simple lancet. The COBAS b 101 system is used for evaluating the sample.
Measured: Day 90
Hand grip strength
Measurement with the Lafayette Digital Hand Dynamometer 5030D1 on the dominant limb. The participant is seated with the elbow flexed at 90 degrees, the shoulder at 0 degrees of flexion, and the wrist in a neutral position. Three grips are performed with 30 seconds of rest between each, and the best of the three measurements is recorded.
Measured: Day 1
Hand grip strength
Measurement with the Lafayette Digital Hand Dynamometer 5030D1 on the dominant limb. The participant is seated with the elbow flexed at 90 degrees, the shoulder at 0 degrees of flexion, and the wrist in a neutral position. Three grips are performed with 30 seconds of rest between each, and the best of the three measurements is recorded.
Measured: Day 90
Sarcopenia
The SARC-F questionnaire, validated for the Portuguese population, is used for assessment.
SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) and were dichotomized to represent symptomatic (4+) vs. healthy (0-3) status.
Measured: Day 1
Sarcopenia
The SARC-F questionnaire, validated for the Portuguese population, is used for assessment.
SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) and were dichotomized to represent symptomatic (4+) vs. healthy (0-3) status.
Measured: Day 90
Fragility
The FRAIL Scale questionnaire, validated for the Portuguese population is used for assessment. The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight. Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status.
Measured: Day 1
Fragility
The FRAIL Scale questionnaire, validated for the Portuguese population is used for assessment. The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight. Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status.
Measured: Day 90
Food diary
The participants are asked to keep a three-day non-consecutive food diary (two weekdays and one weekend day) before and after the intervention.
Measured: Day 1
Food diary
The participants are asked to keep a three-day non-consecutive food diary (two weekdays and one weekend day) before and after the intervention.
Measured: Day 90
Cardiovascular Risk
The SCORE (Systematic COronary Risk Evaluation) algorithm is applied to individuals between the ages of 40 and 69.The SCORE2 algorithm is used in individuals aged between 70 and 89 years.
Measured: Day 1
Cardiovascular Risk
The SCORE (Systematic COronary Risk Evaluation) algorithm is applied to individuals between the ages of 40 and 69.The SCORE2 algorithm is used in individuals aged between 70 and 89 years.
Measured: Day 90
Bicep Skinfold
The measurement of bicep skinfold thickness is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 1
Bicep Skinfold
The measurement of bicep skinfold thickness is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 90
Tricep Skinfold
The measurement of tricep skinfold thickness is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 1
Tricep Skinfold
The measurement of tricep skinfold thickness is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 90
Arm circumference
The measurement of arm circumference is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 1
Arm circumference
The measurement of arm circumference is assessed according to the methodology established by ISAK (International Society for the Advancement of Kinanthropometry).
Measured: Day 90
Lean body mass
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Measured: Day 1
Lean body mass
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Measured: Day 90
Arm muscle area
The formula suggested by Frisancho was used.
Measured: Day 1
Arm muscle area
The formula suggested by Frisancho was used.
Measured: Day 90
Legume intake
Number of plant-based meals (with legumes) per week.
Measured: Day 1
Legume intake
Number of plant-based meals (with legumes) per week.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start30 Jun 2023
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Católica Portuguesa
- Sponsor type
- University, hospital or other
- Collaborators
- Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113484
- Sponsor's protocol ID
- 22/2023/CEFCM
- Acronym
- RATE
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mediterranean Diet (gReenheArTediEt - RATE) on Cardiovascular Disease Risk Factors: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06113484
- Acronym / sponsor ID
- RATE / 22/2023/CEFCM
- Conditions
- Cardiovascular Disease Risk
- Keywords
- Cardiovascular disease, Risk factors, Mediterranean Diet, Plant-based Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade Católica PortuguesaUniversity, hospital or other
- Collaborators
- Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This approved and funded research project is part of a larger project titled "Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR): personalized exercise protocol in the rehabilitation after acute myocardial infarction or at risk of cardiovascular disease and knee osteoarthritis, a multicenter clinical intervention study".
The main objective of this work is to quantify the effect of a nutritional and physical activity intervention in improving important risk factors for cardiovascular disease, such as body weight, body composition, and waist circumference.
Detailed description
Cardiovascular diseases are the leading cause of death worldwide and one of the main contributors to diminished quality of life. It is estimated that in the year 2019, approximately 17.9 million individuals died due to this non-communicable disease, accounting for 32% of all global deaths. It is considered that CVDs result from the interaction between genetic predisposition (non-modifiable risk factors) and environmental influences (modifiable risk factors). Environmental factors prevail over others and often lead to negative outcomes through the adoption of poor lifestyles, such as imbalanced nutrition, physical inactivity, smoking, and alcohol habits. These are considered risk factors with direct effects on the pathogenesis of CVDs, and indirectly contribute to increasing the risk for predisposition to chronic diseases such as hypertension, dyslipidemia, overweight, obesity, and diabetes mellitus.
Currently, scientific literature has demonstrated the importance of diet in preventing CVDs and how it can minimize their risk factors. The Dietary Approaches to Stop Hypertension, Mediterranean dietary pattern, vegetarian diet, EAT-Lancet diet, and other dietary strategies have been published in various scientific journals.
Parallel to health, another topic that has gained prominence in the scientific community is environmental degradation derived from current food production. With the projected population growth until 2050, reaching 10 billion, the effects of food production on greenhouse gas emissions, nitrogen and phosphorus pollution, biodiversity loss, and water and land use are predicted to reach such high values that they will lead to the destabilization of the Earth system.
Considering that diet holds both environmental value and promotes cardiovascular health, this study aims to explore more sustainable and health-promoting dietary adaptations. This intervention will be based on principles of the Mediterranean diet, integrating higher consumption of plant sources compared to other mentioned patterns, and also leveraging the benefits of chronobiology, which are important for weight and adiposity control.
RECRUITMENT PLAN Participants will be recruited from the Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR) project, carried out under the Algarve Biomedical Center - Research Institute. After the participants are integrated into the A3-COR project, those who meet the requirement of never having suffered from AMI but have high cardiovascular disease risk criteria according to the SCORE2 or SCORE2 O.P. algorithm will be contacted by phone. At this point, the objective of the nutritional intervention and the necessary conditions for participation will be explained (assessment of the remaining inclusion and exclusion criteria). After verifying these criteria, they will be invited to voluntarily participate in the present study. Those who accept to join the study will be contacted again to schedule the initial evaluation, and must sign the informed consent form prior to that.
PARTICIPANTS ALLOCATION Participants of the A3-COR control group who agree to participate in the present study (RATE) undergo an initial evaluation, forming the group (NO DIET + NO EXERCISE). These participants were randomly selected using new computer-generated numbers until a sample of 30-35 participants was reached from the total of 74 participants in this group. Participants from the Exercise Group of the A3-COR project who express interest in participating in the RATE project undergo randomization by numbers into one of two groups: the (EXERCISE + NO DIET n=30-35) group, which continues the exercise sessions as planned in the A3-COR project, and the (EXERCISE + DIET n=30-35) group, which, in addition to the exercise sessions, also receives nutritional guidance. This randomization is conducted among the 74 participants in the Exercise Group of the A3-COR project.
STATISTICS The statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 27.0. All normally distributed numerical variables will be presented in the format of mean ± standard deviation. The normality of the variables will be tested using the Kolmogorov-Smirnov test. Differences between groups will be determined using paired t-tests. Repeated measures ANOVA will be used to detect changes between and within groups. Results will be considered statistically significant for p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIET + EXERCISE | Experimental | Other: DIET + EXERCISEThis group engages in physical exercise plus a nutritional intervention. Monthly individual nutrition consultations are conducted. Additionally, this group also benefits from a group culinary workshop. |
| WITHOUT DIET + EXERCISE | Other | Other: WITHOUT DIET + EXERCISEThis group engages in physical exercise; however, it is not the target of the nutritional intervention. Only a group educational session is conducted. |
| WITHOUT DIET + WHITOUT EXERCISE (CONTROL) | No intervention | –This group does not engage in physical exercise, nor is it the target of the nutritional intervention. Only a group educational session is conducted. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal to or greater than 50 years
- Individuals meeting the criteria for high cardiovascular disease risk in the SCORE2 or SCORE2 O.P algorithm
- Autonomy in activities of daily living
- Provide informed and clarified consent
Key exclusion criteria (4 listed)
- Occurrence of Acute Myocardial Infarction (AMI)
- To receive nutritional counseling from a registered dietitian
- To follow a vegetarian or strict vegetarian dietary pattern
- To take nutritional supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIET + EXERCISEAt first, a two-hour group session titled 'Discovering New Flavors' is conducted. This session aims to promote the consumption of healthy foods that should be included in the participants' daily diet. In order to create a different dynamic and enhance interaction, some recipe suggestions are prepared in a group setting. The intervention group is advised to have three (breakfast, lunch, and dinner) to four (breakfast, lunch, afternoon snack, and dinner) daily meals. Participants are encouraged not to count calories, thus emphasizing the importance of moderation. Regarding the main meals, legumes are recommended as a protein source for dinner. On the other hand, for lunch, the protein component can include white meats, fish, or eggs. Red and/or processed meats are excluded in this intervention. Moreover, all participants in this group are encouraged to practice a nightly fasting period of at least 12 hours. | Other | DIET + EXERCISE |
| WITHOUT DIET + EXERCISEAn educational session titled "Healthy Eating: Nutritional Recommendations for Individuals at Risk of Cardiovascular Disease" will be conducted in a group setting. The objective of this session is to raise awareness among participants about the importance of a healthy diet and lifestyle in the prevention of cardiovascular diseases. | Other | WITHOUT DIET + EXERCISE |
Primary outcome
Body weight (kg)
Time frame: Day 1
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions
Body weight (kg)
Time frame: Day 90
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions
Body fat (%)
Time frame: Day 1
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Body fat (%)
Time frame: Day 90
Medical Body Composition Analyzer - SECA® mBCA 514/515 - The subjects are placed standing on the scale in accordance with the manufacturer's instructions.
Waist circumference (cm)
Time frame: Day 1
The abdominal circumference is assessed using a measuring tape at the midpoint between the upper edge of the iliac crest and the last palpable rib, following the methodology established by ISAK (International Society for the Advancement of Kinanthropometry)
Waist circumference (cm)
Time frame: Day 90
The abdominal circumference is assessed using a measuring tape at the midpoint between the upper edge of the iliac crest and the last palpable rib, following the methodology established by ISAK (International Society for the Advancement of Kinanthropometry)
28 secondary outcomes
Lipid profile
Time frame: Day 1
Lipid profile
Time frame: Day 90
Hemoglobin A1c
Time frame: Day 1
Hemoglobin A1c
Time frame: Day 90
C-reactive protein
Time frame: Day 1
C-reactive protein
Time frame: Day 90
Hand grip strength
Time frame: Day 1
Hand grip strength
Time frame: Day 90
Sarcopenia
Time frame: Day 1
Sarcopenia
Time frame: Day 90
Fragility
Time frame: Day 1
Fragility
Time frame: Day 90
Food diary
Time frame: Day 1
Food diary
Time frame: Day 90
Cardiovascular Risk
Time frame: Day 1
Cardiovascular Risk
Time frame: Day 90
Bicep Skinfold
Time frame: Day 1
Bicep Skinfold
Time frame: Day 90
Tricep Skinfold
Time frame: Day 1
Tricep Skinfold
Time frame: Day 90
Arm circumference
Time frame: Day 1
Arm circumference
Time frame: Day 90
Lean body mass
Time frame: Day 1
Lean body mass
Time frame: Day 90
Arm muscle area
Time frame: Day 1
Arm muscle area
Time frame: Day 90
Legume intake
Time frame: Day 1
Legume intake
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIET + EXERCISE and WITHOUT DIET + EXERCISE in people with Cardiovascular Disease Risk, run by Universidade Católica Portuguesa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.